Prosthetic penile implants with tethered rear tip extenders and related methods

ABSTRACT

Rear tip extenders having a tether attached to a collar for penile implants that can be mounted onto a respective cylinder forward of a fluid line (that communicates with a scrotal pump) to prevent full separation or detachment from the cylinder during a revision procedure can be fabricated by molding. The fabrication methods include: providing a mold with a mold cavity configured to define three attached members of defined shapes, including a rear tip extender, a collar and a tether attaching the rear tip extender and collar; and flowably introducing moldable material into the mold cavity to form the collar, rear tip extender and attached tether as a molded assembly.

RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 14/312,999 filed Jun. 24, 2014, which claims the benefit of andpriority to U.S. Provisional Application Ser. No. 61/841,959 filed Jul.2, 2013, the contents of which are hereby incorporated by reference asif recited in full herein.

FIELD OF THE INVENTION

This invention relates to prosthetic penile implants.

BACKGROUND OF THE INVENTION

Prosthetic penile implants have been used for many years to allow menwith erectile dysfunction to achieve erection. Penile implants areavailable as inflatable or non-inflatable devices. Inflatable penileprostheses are available in two- and three-piece configurations. Each ofthe so-called two and three piece configurations have a pair of elongateintracorporeal cylinders 20 (which are counted as a single one of thetwo or three component systems) and a scrotal pump 50. Typically, thecylinders 20 of such a prosthetic device are implanted into the corpuscavernosae and the pump 50 is implanted in the scrotum (e.g., a scrotalpump). The three-piece configuration, an example of which is shown inFIG. 1, has a separate reservoir 30 that connects via tubing to thescrotal pump 50. The reservoir 30 is typically implanted in the abdomen,pelvis, or in an ectopic location under the abdominal wall. Thetwo-piece configuration, an example of which is shown in FIG. 2, doesnot require the separate reservoir. Instead, the two-piece configurationuses rear tip cylinder reservoirs 26 that transfer fluid into centercylinder chambers 20 which, once full, do not expand, but the fluid inthe center chambers pressurize to provide penile rigidity. Acommercially available, two-piece inflatable penile prostheses is theAMS Ambicor® from American Medical Systems (AMS). Different models of athree-piece inflatable penile prosthesis are available from AMS andColoplast Corporation, MN, the latter including the Titan™ inflatableprosthesis.

An inflatable penile prosthesis can be implanted so that a respectivecylinder is inserted into the corpus cavernosum with the proximal end ofthe cylinder (the rear tip) residing toward the pubic bone.

To achieve a proper fit, the surgeon may select one or more rear tipextenders (RTEs) 25 of a suitable length to attach onto the rear of thecylinder. The RTE may be in the form of cap (e.g., a silicone rubbercap) that fits onto the rear of the cylinder to extend the length asuitable amount. In some cases, more than one RTE is attached to therear end of the cylinder 20. In any event, typically, these RTEs areattached to the rear end of the cylinder via friction fit and separationof the components is inhibited by a vacuum that results when they arepulled in opposite directions.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Embodiments of the invention provide a rear tip extender that istethered to a collar that can be mounted onto a respective cylinder infront of a fluid line to and from a scrotal pump to prevent fullseparation or detachment from the cylinder during a revision procedure.

Embodiments of the invention are directed to rear tip extenderassemblies for a penile prosthesis implant. The RTE assemblies include:a rear tip extender and/or rear tip cap sized and configured to attachto an elongate cylinder of a penile prosthesis implant; a collar that issized and configured to reside against an outer surface of the cylinder;and at least one tether that is attached to the rear tip extender andthe collar.

The rear tip extender can be a rear tip cap.

The rear tip cap can be formed of silicone rubber.

The collar and rear tip extender can include an elastomeric material andthe tether can be integrally moldably attached to at least one of thecollar and rear tip extender.

The tether can be integrally moldably attached to both the collar andrear tip extender.

The tether can be a single tether and the collar and tether can have anintegral monolithic configuration that is sized and configured toslidably travel over a forward end of the cylinder and, in position, canreside in front of and proximate to a fluid line that extends outwardfrom a rear portion of the cylinder.

The collar can include at least one substantially arcuate longitudinallyextending recess.

The collar can include a plurality of circumferentially spaced apartsubstantially arcuate recesses.

The rear tip extender assembly can be in combination with at least oneother rear tip extender assembly and rear tip assembly can have adifferent length rear tip extender.

Other embodiments are directed to penile prosthesis implants. Theimplants include: (a) an elongate cylinder having longitudinallyopposing front and rear end portions, the rear end portion comprising afluid conduit junction; (b) a collar on the cylinder residing adjacentto the fluid conduit junction; (c) a rear tip extender attached to therear end portion of the cylinder; and (d) at least one tether attachedto the collar and the rear tip extender.

The rear tip extender can be a rear tip cap.

The rear tip cap and at least one tether can be of silicone rubber.

The collar and the rear tip extender can be formed of an elastomericmaterial and the at least one tether can be integrally moldably attachedto at least one of the collar and rear tip extender.

The at least one tether can be a single tether that is integrallymoldably attached to both the collar and rear tip extender.

The collar can be a single, monolithic member that is sized andconfigured to slidably travel over a forward end of the cylinder toreside adjacent the fluid junction.

The collar can include at least one substantially arcuate longitudinallyextending recess.

Yet other embodiments are directed to methods of configuring a penileprosthesis implant for insertion into a patient. The methods include:(a) providing a pair of elongate cylinders with longitudinally opposingfront and rear end portions, the rear end portions having a fluidjunction with a fluid line extending away from the cylinder and a rearend; (b) sliding a collar having a longitudinally extending tetherattached to a rear tip extender over a front end portion of eachrespective cylinder to a position adjacent the fluid line junction; and(c) placing a rear tip extender on the rear end of the cylinder therebytethering the rear tip extender to the collar.

Yet other embodiments are directed to methods of fabricating a penileimplant, including: (a) providing a mold with a mold cavity configuredto define three attached members of defined shape, including a rear tipextender, a collar and a tether attaching the rear tip extender andcollar; and (b) flowably introducing moldable material into the moldcavity to form the collar, rear tip extender and attached tether as amolded assembly.

Embodiments of the invention include providing instructional mediashowing the method of configuring a penile prosthesis implant forinsertion into a patient.

The foregoing and other objects and aspects of the present invention areexplained in detail in the specification set forth below.

It is noted that aspects of the invention described with respect to oneembodiment, may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail in the specification set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of an exemplary three-piece prior artprosthetic implant.

FIG. 2 is a side perspective view of an exemplary two-piece prior artprosthetic implant.

FIG. 3 is a side view of a cylinder with a RTE assembly for a penileimplant according to embodiments of the invention.

FIG. 4 is a top view of the device shown in FIG. 3.

FIG. 5 is a side perspective view of the device shown in FIG. 3.

FIG. 6 is an end view of the device shown in FIG. 3.

FIG. 7A is an enlarged view of a cylinder illustrating an exemplaryassembly procedure for a collar with tether attachment and RTE accordingto embodiments of the present invention.

FIG. 7B is an enlarged front perspective view of the device shown inFIG. 3 according to embodiments of the present invention.

FIG. 7C is a partial side perspective schematic illustration of analternate embodiment of the collar and tether according to embodimentsof the present invention.

FIG. 7D illustrates the collar and tether embodiment shown in FIG. 7Cseparate from the implant cylinder.

FIG. 8 is an enlarged rear side perspective view of the device shown inFIG. 1 illustrating a two-piece snap fit collar construction accordingto embodiments of the present invention.

FIG. 9A is a schematic side perspective view of an alternate RTEassembly according to embodiments of the present invention.

FIG. 9B is a schematic illustration to show that two RTE assemblies canbe used together according to embodiments of the present invention.

FIG. 10 is a side perspective view of another RTE/collar/tetherembodiment according to embodiments of the present invention.

FIG. 11 is a side schematic view of a kit of RTE assemblies according toembodiments of the present invention.

FIG. 12 is a flow chart of exemplary operations or actions that can becarried out to assemble an RTE assembly according to embodiments of thepresent invention.

FIG. 13 is a flow chart of an exemplary fabrication process for an RTEassembly according to embodiments of the present invention.

FIG. 14A is a schematic perspective view of an exemplary mold for anintegral RTE assembly according to embodiments of the present invention.

FIG. 14B is a schematic perspective view of an exemplary set of corerods that may be used to form a tethered RTE according to embodiment ofthe present invention.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention will now be described more fully hereinafter withreference to the accompanying figures, in which embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Like numbers refer to like elementsthroughout. In the figures, certain layers, components or features maybe exaggerated for clarity, and broken lines illustrate optionalfeatures or operations unless specified otherwise. In addition, thesequence of operations (or steps) is not limited to the order presentedin the figures and/or claims unless specifically indicated otherwise. Inthe drawings, the thickness of lines, layers, features, componentsand/or regions may be exaggerated for clarity and broken linesillustrate optional features or operations, unless specified otherwise.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms, “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises,”“comprising,” “includes,” and/or “including” when used in thisspecification, specify the presence of stated features, regions, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, regions, steps,operations, elements, components, and/or groups thereof.

It will be understood that when a feature, such as a layer, region orsubstrate, is referred to as being “on” another feature or element, itcan be directly on the other feature or element or intervening featuresand/or elements may also be present. In contrast, when an element isreferred to as being “directly on” another feature or element, there areno intervening elements present. It will also be understood that, when afeature or element is referred to as being “connected”, “attached” or“coupled” to another feature or element, it can be directly connected,attached or coupled to the other element or intervening elements may bepresent. In contrast, when a feature or element is referred to as being“directly connected”, “directly attached” or “directly coupled” toanother element, there are no intervening elements present. Althoughdescribed or shown with respect to one embodiment, the features sodescribed or shown can apply to other embodiments. The term “distal”refers to a direction or location that is closer to or toward a patientwhile the term “proximal” refers to the opposing direction or a locationthat is further away from the patient.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the present applicationand relevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein.

The term “tether” refers to a flexible or semi-rigid member that extendsbetween and attaches two separate components.

The term “about” means that the recited number or value can vary by+/−20%.

The term “sterile” means that the noted device or material meets orexceeds defined medical guidelines of cleanliness and is substantially(if not totally) without contaminants so as to be suitable for medicaluses.

The term “semi-rigid” means that the implant is flexible but hassufficient rigidity to substantially maintain its three-dimensionalshape under normal loading in the body.

The term “instructional media” refers to electronic and/or papermanuals, videos, user guides, or the like illustrating and/or describingpre-surgical assembly steps and/or a surgical procedure using thetethered penile implant.

Referring now to the figures, FIGS. 3-6 illustrate a cylinder 20 of aninflatable penile implant 10 (FIG. 1, 2) according to embodiments of thepresent invention. The cylinder 20 has longitudinally opposing front(forward) and rear end portions 20 f, 20 r. As shown, a collar 60resides on the cylinder 20 on the rear end portion 20 r proximate afluid junction 40 j at which junction the flexible tube or conduit 40extends to connect the scrotal pump 50 (FIGS. 1, 2). The collar 60includes at least one attached tether 70 that is also attached to therear extender tip 25. The tether 70 can be a single longitudinallyextending tether or may be a plurality of longitudinally extending,circumferentially spaced apart tethers (not shown).

The tether 70 is typically attached to or integrally formed onto a wallor the outer surfaces of both the collar 60 and the RTE 25. Althoughshown in most embodiments as a single tether, more than one tether maybe used.

The tether 70 can comprise a thread, strap, suture, wire or otherelongate member. The tether 70 can be flexible. The tether 70 can besemi-rigid. The tether 70 can be an integrally molded component of thecollar 60.

The collar 60 can be a unitary monolithic component of suitable medicalgrade material. The collar 60 can comprise silicone rubber or othermedical grade suitable elastomeric or polymeric material. The collar 60can also comprise a biocompatible, non-cytotoxic metal or ceramic. Thecollar 60 can comprise a combination of materials.

The collar 60 can include at least one arcuate recess 61 (FIGS. 7A, 8).The arcuate recess 61 can be aligned to abut the fluid junction 40 j sothat the conduit junction or conduit extension 40 resides therein (FIG.9). The recess 61 can receive the extension 40 j which may angle out ofthe cylinder 20 at about 45 degrees or other angles (FIG. 3).

The collar 60 can be provided in different sizes for different sizes ofcylinders 20. The collar 60 can optionally abut the outer surface of thecylinder 20 at the rear end portion 20 r or may reside loosely againstthe outer surface of the cylinder 20 (e.g., so as to not contact atleast a portion of the outer wall of the cylinder thereat). The collar60 can have any suitable axial length and any suitable cross-sectionalwidth and is not required to matably correspond to the cylinder outerdiameter. The collar 60 can be between about 0.1 inches to about 0.5inches in axial length but other lengths may also be suitable.

In some embodiments, the collar 60 can have an axially extendingcenterline 60 c that is concentric with an axially extending centerline20 c of the cylinder 20 as shown in FIGS. 1-6, for example.

In some embodiments, as shown in FIG. 7C, the collar 60 can have atransversely extending centerline 60 t that angles away from the outerwall of the cylinder so that the centerlines 20 c, 60 t are offset fromeach other, typically between about 10 degrees to about 75 degrees ineither a forward or rearward tilt orientation (shown in FIGS. 7C and 7Das in a rearward tilt orientation).

The collar 60 can be configured to be able to expand in response toinflation/expansion of the cylinders 20 so as not to provide unduecompression on the cylinder when in an expanded configuration. Thecollar 60 can have an accordion, undulated or pleated segment orsegments to facilitate expansion and/or may be formed of a resilient,flexible and/or otherwise expandable material.

In some embodiments, the collar 60 can reside loosely against the outerwall of the cylinder and is not required to expand with the expansion ofthe cylinder 20. The collar 60 can have an inner wall with across-sectional width that is 10-50% larger than an outer diameter ofthe cylinder 20.

The collar 60 can be in the shape of a disk (e.g., with a substantiallycircular opening). The collar 60 can be in other shapes not requiring acircular opening or circular external outer Wall shape. The collar 60can have any closed geometric shape, e.g., oval, polygonal, triangularand the like.

The tether 70 can have the same material as the collar 60 or the RTE 25or may comprise a different material. The tether 70 has a lengthsufficient to extend from at least a front end portion of the RTE 25 tothe collar 60; typically, the tether 70 has a length between about 0.5inches to about 10 inches, typically between about 0.5 inches to about 5inches. The tether 70 can be longer as it can reside in local tissue andwhen pulled, it pulls the RTE along with the collar upon a revision orother surgery to provide a positive retention of the two components.

As shown in FIG. 3, for example, the tether 70 can be thin. The tether70 can have a small width, such as a width that is between about 0.001inches to about 0.1 inches. In other embodiments, the tether 70 can havea greater width, but if so, the width is typically less than about 40%of the circumference, e.g., between about 1% to about 40% of thecircumference. The tether 70 can be configured to reside closely spacedto the body of the cylinder 20 when the RTE 25 and collar 60 are inposition on the cylinder 60.

The RTE 25 can be a rear tip end cap (with a closed end tip) as shown inFIGS. 3-6.

In some embodiments, the collar 60, tether 70 and RTE 25 can be providedpre-assembled as an assembly 25 a and provided in a kit 100 of differentsizes of RTEs 25 (FIG. 11). The surgeon or other clinician can select anappropriate assembly 25 a for use when sizing the patient's anatomicalrequirements. An assembly 25 a can be attached to each respectivecylinder 20 prior to placement in a patient.

In some embodiments, the tether 70 is moldably attached to the collar 60and RTE 25. In some embodiments, the tether 70 is adhesively attached tothe respective collar 60 and/or RTE 70. In some embodiments, the collar60 is mechanically fastened to the tether 70 and/or RTE 70 using, forexample, hooks, VELCRO (e.g., loop and hook), or mechanical slide andchannel, tongue and groove, rivets, pins or clamp attachmentconfigurations.

In some embodiments, the assembly 25 a includes a single RTE 25 andtether 70 attached to a respective collar 60 as shown, for example, inFIG. 11. In other embodiments, as shown in FIG. 9A, the subassembly 25a′ can include the collar 60 attached to two or more RTEs, including amedial and end cap RTE 25 m, 25 c, using two or more tethers 70 ₁, 70 ₂.In some embodiments, as shown in FIG. 9B, two RTE assemblies 25 a withrespective at least one tether and collar can be used on a singlecylinder 20. The collars 60 ₁, 60 ₂ can reside in abutting contact andthe respective tethers 70 ₁, 70 ₁ can attach to different RTEs 75 (shownas 25 m and 25 c, for example).

FIG. 7A illustrates a sequence of steps that can be used to position theassembly 25 a onto the cylinder 20. As shown, first (1) the assembly 25a is aligned with the cylinder so that the collar 60 slides onto thetapered forward end of the cylinder. Next (2), the collar 60 (with theRTE 25 attached and able to be move side to side relative to thecylinder while attached to the tether 70) is slid back to resideadjacent the fluid line junction 40 j. Then (3) the RTE 25 can beattached to the rear end of the cylinder 20. The RTE 25 is then tetheredto the collar 60 and the fluid junction provides a hard “stop” so thatthe RTE 25 remains attached to the collar 60 even if it becomes detachedfrom the cylinder end.

FIG. 7B illustrates position (3), the use/implant configuration. FIG. 7Balso illustrates the arcuate recesses 61 and the integral (moldablyattached) configuration of the tether 70 to the collar 60 and/or the RTE25.

FIGS. 7C and 7D illustrate a hoop-like collar 60 that can reside at anoblique angle with respect to the cylinder 20. As shown, a line drawnthrough a centerline 60 t of the collar 60 can intersect the axialcenterline 20 c of the cylinder 20 typically at an angle α that isbetween about 10-75 degrees. The centerline 60 t can be described as atransversely extending centerline as it is in a width dimension of thecollar. This configuration may allow expansion of the cylinder 20without exertion of compression onto the cylinder when in an expandedconfiguration.

FIG. 8 illustrates an alternate embodiment where the collar 60 is atwo-piece collar 60 a, 60 b with two (substantially) circumferentiallyextending segments that can be attached about the cylinder 20 after itis in position proximate the fluid junction 40 j to avoid the step ofsliding the collar over the cylinder 20. The attachment can be a bayonetfit, snap-fit or other mechanical fastening configuration. Adhesive maybe used but is not preferred.

As the RTEs 25 can be provided in different lengths, the collars 60 ortethers 70 (or both) can be color-coded to represent a length of the RTEfor facilitating physician size selection.

FIG. 10 illustrates that the tether 70′ can be attached to the collar 60and/or RTE 25 after the RTE size is selected, e.g., the devices can beprovided as separate components that can be assembled by a clinicianprior to implantation of the device. The tether 70′ can be attached toattachment members on the respective collar 60 and RTE 25. In someembodiments, the tether 70′, collar 60 and RTE 25 are all provided asseparate components and the tether 70′ is attached in situ. In someembodiments, the collar and tether 60, 70 are provided as an assemblythat is attached to the RTE 25 when the RTE size is selected for apatient. In some embodiments, the tether 70′ and RTE 25 are provided asan assembly that is then attached to the collar 60 proximate to orduring a surgical preparation or the actual surgery, typically after thecollar 60 is in position on the cylinder 20.

FIG. 12 is a flow chart of exemplary operations that can be used tocarry out embodiments of the present invention: The method can include:providing a penile implant with elongate cylinders (block 225); placinga collar onto a front end of respective cylinders (block 230); slidingthe collars over the respective cylinder to place the collar proximate afluid junction at a rear end portion of the respective cylinder (block240); then, placing a rear tip extender onto the rear end portion of thecylinder thereby tethering the rear tip extender to the cylinder (block245).

The method may optionally include providing a plurality of collars, eachattached to a different length rear tip extender (block 227). Thecollars can be color-coded to designate a particular length rear tipextender (block 228).

The placing steps can be carried out at a surgical site prior toimplanting the cylinder in a patient (block 247).

FIG. 13 is a flow chart of exemplary steps of fabrication methods forfabricating an RTE assembly according to embodiments of the presentinvention. A mold is provided, the mold having a mold cavity defining arear tip extender, collar and tether attaching the rear tip extender andcollar (block 270). Moldable material is introduced into the mold cavity(block 275). A rear tip extender, collar and tether are formed as anintegral (molded) assembly (block 280).

The mold shape for the collar can include arcuate regions that formlongitudinally extending arcuate recesses in the collar (block 272). Themoldable material can include (or be made totally of) silicone rubber(block 277).

The method can include sterilizing the assembly for medical use (block282).

FIG. 14A is a schematic illustration of a mold 300 that has a moldcavity 301 with a cavity shape and internal mold members 320, 321, 325that form an integral RTE 25, collar 60 and tether 70 attached to bothaccording to embodiments of the present invention. The mold 300 can befor injection molding or blow molding, for example. FIG. 14B illustratescooperating core rods 325 r, 326 with shapes that can form the collarwith arcuate recess according to some embodiments of the presentinvention.

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. In the claims, means-plus-function clauses, if used, areintended to cover the structures described herein as performing therecited function and not only structural equivalents but also equivalentstructures. Therefore, it is to be understood that the foregoing isillustrative of the present invention and is not to be construed aslimited to the specific embodiments disclosed, and that modifications tothe disclosed embodiments, as well as other embodiments, are intended tobe included within the scope of the appended claims. The invention isdefined by the following claims, with equivalents of the claims to beincluded therein.

That which is claimed is:
 1. A method of fabricating a penile implant,comprising: providing a mold with a mold cavity configured to definethree attached members of defined shapes, including a rear tip extender,a collar and a tether attaching the rear tip extender and collar; andflowably introducing moldable material into the mold cavity to form thecollar, rear tip extender and attached tether as a molded assembly. 2.The method of claim 1, further comprising sterilizing the moldedassembly for medical use.
 3. The method of claim 1, wherein the rear tipextender is sized and configured to attach to an end portion of anelongate cylinder of a penile prosthesis implant, wherein the collar issized and configured to reside against an outer surface of the cylinder,and wherein the collar is sized to be loosely held on the cylinder withan inner diameter that is between 10-50% greater than an outer diameterof the cylinder and/or is configured to expand when the cylinder expandsdue to inflation.
 4. The method of claim 1, wherein the rear tipextender comprises a rear tip cap with a closed end.
 5. The method ofclaim 1, wherein the moldable material comprises silicone rubber.
 6. Themethod of claim 1, wherein the collar comprises at least one arcuaterecess.
 7. The method of claim 1, wherein the collar comprises aplurality of circumferentially spaced apart arcuate recesses.
 8. TheMethod of claim 1, wherein the providing the mold is a first mold toform a first molded assembly with the collar, rear tip extender andattached tether, and wherein the method further comprises: providing asecond mold with a mold cavity configured to define three attachedmembers of defined shapes, including a rear tip extender, a collar and atether attaching the rear tip extender and collar; and flowablyintroducing moldable material into the mold cavity of the second mold toform the collar, rear tip extender and attached tether as a secondedmolded assembly, wherein the rear tip extender of the second moldedassembly has a shorter or longer length than the rear tip extender ofthe first molded assembly.
 9. The method of claim 8, wherein the collar,tether and/or rear tip extender of the second molded assembly has adifferent color than the collar, tether and/or rear tip extender of thefirst molded assembly.
 10. The method of claim 1, wherein the tether isa single tether.
 11. The method of claim 1, wherein the tether has awidth that is between about 0.001 inches to about 0.1 inches.
 12. Themethod of claim 1, wherein the collar is between about 0.1 inches toabout 0.5 inches in axial length.
 13. The method of claim 1, wherein thetether has a length between about 0.5 inches to about 10 inches.
 14. Themethod of claim 1, wherein the tether has a length between about 0.5inches to about 5 inches and a width between about 0.001 inches to about0.1 inches.
 15. The method of claim 1, further comprising providing atleast one core rod to cooperate with the mold cavity, the at least onecore rod shaped to form the collar to have at least one arcuate recess.